To clarify the clinical effects of Shengdi Dahuang Decoction in the treatment of acute hemorrhagic stroke and to explore the possible mechanism. Participants will take the granules of Shengdi Dahuang Decoction that contains 15 grams of rehmannia and 5 grams of rhubarb, one pack per time, twice a day for 7 days.

To explore the effective clinical therapy in acute hemorrhagic stroke. Participants will take placebo contains 2% rehmannia and rhubarb, one pack per time, twice a day for 7 days.

Hemorrhagic Stroke

Shengdi Dahuang Decoction contains Shengdi (rehmannia) and Dahuang ( rhubarb). Each pack of the granules of Shengdi Dahuang Decoction contains 15 grams of rehmannia and 5 grams of rhubarb.

Granules of Shengdi Dahuang Decoction

Placebo granules has the same appearence, weight, shape and color as the experimental drug.

Placebo

Shanghai seventh People's Hospital, Seventh People's Hospital of Shanghai University of TCM

Shanghai Sixth People's Hospital affiliated to Shanghai Jiaotong University

Shanghai Tenth People's Hospital, Tenth People's Hospital of Tongji University

Shuguang Hospital affiliated with Shanghai University of TCM

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

A Randomized, Controlled, Double-blind, Multi-center Clinical Study of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

Modified Rankin Scale score (mRS) will be graded on the 90th day after onset (mRS score ranges from 0 point (no symptoms at all) to 5 points (severe disability)).

The proportion of deaths (mortality rate, %) in different groups on 7th day after treatment will be compared.

The proportion of deaths (mortality rate, %) in different groups on 90th day after treatment will be compared.

National Institute of Health Stroke Scale (NIHSS) will be used to assess the severity of neurological deficit on the 7th day after treatment. NIHSS score ranges from 0 point to 42 points. More severe neurological deficit could be observed in participants with the higher score.

All participants will reexamine the skull CT scan 24 hours after onset. The volume of hematoma (ml) increases more than 6ml or 33% relative increment than original volume is defined as the expansion of hematoma. The proportion of hematoma enlargement cases (%) will be compared between different groups.

All participants will reexamine the skull CT scan on the 7th day after treatment. The volume (ml) of edema and hematoma will be calculated respectively. The ratio of edema volume and hematoma volume represents the severity of edema.

Xiaofei Yu

Clinical Professor

ShuGuang Hospital

One dosage of Chinese herbal medicine by oral administration per day for 8 weeks. For patients who cannot take oral medicine can be switched to colon route by the colonic therapy system（IMS-100A produced by Sunny Medical in Beijing China).

Patients in the control group only receive the standard medical treatment (SMT), no control drug with CHM.

Acute on Chronic Liver Failure

Traditional Chinese Medicine

Hepatitis B

One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.

Chinese herbal medicine

SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.

Control (blank)

302 military hospital of China

Beijing Ditan hospital

Beijing youan hospital

Fuzhou infectious hospital

Xiamen hospital of traditional Chinese medicine

Hubei hospital of traditional Chinese medicine

Tongji hospital, Huazhong university of science and technology

The first affiliated hospital of Hunan university of traditional Chinese medicine

Jilin hepatology hospital

The sixth people's hospital of Shenyang

Shanghai public health clinical center

Shuguang hospital, Shanghai university of traditional Chinese medicine

Chengdu public health clinical center

The second people's hospital of Tianjin

Hangzhou Xixi hospital

Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

Study on the Optimal Strategy for Acute-on-chronic Liver Failure Combined With Traditional Chinese and Modern Medicine: a Multi-center, Randomized and Controlled Study

transplant free survival at the time point of week 12

transplant free survival at the time point of week 24

compare the MELD score between the two arms. MELD is the abbreviation of model for end-stage liver disease involving serum bilirubin, creatinine, international normalized ratio (INR) and sodium.

compare the Child-Pugh score between the two arms. Child-Pugh score is the panel involving the serum bilirubin, coagulation function, albumin and the complication of hepatic encephalopathy and ascites.

compare the life quality based on WHOQOL-BRIEF between the two arms

incidence of liver related complications of the two arms including infections, encephalopathy, hepatorenal syndrome (HRS), and gastrointestinal bleeding.

rhubarb/krvarenje

Clinical Evaluation of Shengdi Dahuang Decoction in the Treatment of Acute Hemorrhagic Stroke

Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From Cerebral Hemorrhage

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